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| Product NDC Code | 82123-009 | ||||
|---|---|---|---|---|---|
| Drug Name | Propolis nasal |
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| Type | Brand | ||||
| Pharm Class | Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC] |
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| Active Ingredients |
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| Route | NASAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | M012 | ||||
| Labeler Name | SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient(s) Alcohol 80% v/v. Purpose: Antiseptic
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic, Hand Sanitizer
Spl product data elements
Usually a list of ingredients in a drug product.PROPOLIS NASAL PLUS PLUS NASAL EUCALYPTUS OIL OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE WATER SEA SALT PROPOLIS WAX GLYCERIN PROPOLIS NASAL NASAL EUCALYPTUS OIL SEA SALT GLYCERIN PROPOLIS WAX OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE WATER Sunscreen SPF50 Non Nano Zinc Oxide WATER BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES JOJOBA OIL .ALPHA.-TOCOPHEROL ACETATE ZINC OXIDE ZINC OXIDE PROPOLIS WAX PANTHENOL COCO-CAPRYLATE/CAPRATE MAGNESIUM SULFATE ANHYDROUS ALOE VERA LEAF ARGAN OIL DICAPRYLYL CARBONATE SODIUM STEAROYL GLUTAMATE GLYCERYL CITRATE GLYCERIN Sunscreen for Face SPF50 Non Nano Zinc Oxide COCO-CAPRYLATE/CAPRATE OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES ZINC OXIDE ZINC OXIDE ALOE VERA LEAF DICAPRYLYL CARBONATE PANTHENOL BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES MAGNESIUM SULFATE ANHYDROUS GLYCERYL CITRATE PROPOLIS WAX .ALPHA.-TOCOPHEROL ACETATE WATER GLYCERIN SODIUM STEAROYL GLUTAMATE ARGAN OIL AfterSun Non Nano Zinc Oxide PROPOLIS WAX SODIUM STEAROYL GLUTAMATE PHYSALIS ANGULATA ALOE VERA LEAF GLYCERYL CITRATE ZINC OXIDE ZINC OXIDE WHITE WAX .ALPHA.-TOCOPHEROL ACETATE GLYCERIN PANTHENOL WATER BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES COCO-CAPRYLATE/CAPRATE SESAME OIL XANTHAN GUM ARGAN OIL MAGNESIUM SULFATE ANHYDROUS Diaper Rash Cream Non Nano Zinc Oxide BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) WHITE WAX POLYGLYCERYL-3 OLEATE PANTHENOL COCO-CAPRYLATE/CAPRATE ALOE VERA LEAF GLYCERIN POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE POLYGLYCERYL-3 DIISOSTEARATE CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE .ALPHA.-TOCOPHEROL ACETATE ZINC OXIDE ZINC OXIDE JOJOBA OIL HELIANTHUS ANNUUS SEED WAX POLYGLYCERYL-4 ISOSTEARATE POLYGLYCERIN-3 PALM OIL PALM KERNEL OIL COCONUT OIL CANOLA OIL Sunscreen for kids SPF50 Non Nano Zinc Oxide MAGNESIUM SULFATE ANHYDROUS PALM KERNEL OIL COCONUT OIL CANOLA OIL WATER COCO-CAPRYLATE/CAPRATE BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES ARGAN OIL GLYCERYL CITRATE PROPOLIS WAX .ALPHA.-TOCOPHEROL ACETATE PANTHENOL ZINC OXIDE ZINC OXIDE DICAPRYLYL CARBONATE ALOE VERA LEAF PALM OIL SODIUM STEAROYL GLUTAMATE GLYCERIN S.O.S Cream Intensive Moisturizing Skin Protectant Non Nano Zinc Oxide OLEA EUROPAEA FLOWER WHITE WAX PANTHENOL HONEY PROPOLIS WAX BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES GLYCERIN OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES WATER .ALPHA.-TOCOPHEROL ACETATE, D- ROYAL JELLY ZINC OXIDE ZINC OXIDE Acne Control Serum Salicylic Acid WATER APIS MELLIFERA VENOM HYDROXYETHYL CELLULOSE, UNSPECIFIED BEET CAPRYLIC ACID ROSA MULTIFLORA FRUIT HYALURONIC ACID SALICYLIC ACID SALICYLIC ACID ACTINIDIA POLYGAMA FRUIT XYLITOL TEA TREE OIL GLYCERIN PROPANEDIOL PROPOLIS WAX
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Acne Control Serum 30 ml NDC: 82123-009 Acne Control Serum
Sunscreen for kids SPF50 Sunscreen for kids SPF50 80 mL NDC: 82123-012
Sunscreen for face SPF50 Sunscreen for face SPF50 40 mL NDC: 82123-013
Aftersun AfterSun 80 mL NDC: 82123-004
Diaper Rash Cream Diaper Rash Cream 50 mL NDC: 82123-005 Diaper Rash Cream
Propolis Nasal Plus Nasal Spray Plus NDC: 82123-010
Propolis Nasal Propolis Nasal NDC: 82123-009
SOS Cream SOS Cream SOS Cream
Sunscreen SPF50 Sunscreen SPF50 80 mL NDC: 82123-011
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use in children less than 2 months of age on open skin wounds
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only. Flammable. Keep away from heat or flame
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API